The Food and Drug Administration (FDA) on Friday maintained that it followed the regulatory process in approving one hospital’s application for compassionate use of the antiparasitic drug ivermectin on COVID-19 cases.
This follows Iloilo Representative and former Health Secretary Janette Garin’s warning that the FDA could be held liable for allowing compassionate use of ivermectin, which she claimed was affected by several lawmakers’ push to authorize the drug.
FDA chief Eric Domingo said a compassionate special permit (CSP) was only granted to eligible drugs -- those that had been registered in another country but not available locally or those being used in clinical trials.
“Enough ‘yun para mag-qualify for CSP dito sa atin. Kaya po siya nabigyan ng CSP dahil nag-apply po ‘yung isang ospital at na-submit naman po niya lahat ng requirements na kinakailangan,” Domingo said in a Department of Health (DOH) briefing.
[That’s enough to qualify for CSP here. Ivermectin was given a CSP because one hospital filed an application and submitted all the needed documents.]
Domingo announced that the FDA approved a hospital’s CSP application for ivermectin on Thursday.
He clarified that a CSP was not a marketing authorization, meaning ivermectin could not be sold commercially yet, since the “very limited” permit stated how many tablets had been approved for use and to how many patients it could be given.
Domingo also said a CSP was usually valid for one-time importation within one year only.
“Walang garantiya ang FDA do’n sa quality at saka efficacy ng gamot lalo na kung clinical trial drug pa,” Domingo said.
[The FDA does not guarantee its quality and efficacy, especially if it’s a clinical trial drug.]
Domingo said doctors prescribing a drug approved for compassionate use should take upon themselves "complete responsibility over the product.”
“In fact, kasama ‘yun sa kanilang application na they take full responsibility for the product at of course ang ibig sabihin no’n, idi-discuss nila sa pasyente... at kailangan tanggapin ng pasyente na gagamitin sa kanya ang gamot na ito.”
[In fact, it is stated in their application that they take full responsibility for the product and, of course, that means they will discuss it with the patient and the patient must consent to using the drug.]
While a CSP has been granted to ivermectin, the DOH has vowed to stick to science in its evaluation of the drug as a COVID-19 treatment.
The World Health Organization, European Medicines Agency, and other similar international bodies still do not recommend ivermectin for COVID-19 cases. --NB, GMA News